A Study of Lapatinib in Combination With Caelyx in Patients With Advanced HER2 Positive Pretreated Breast Cancer
Status:
Terminated
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
Summary
A Phase Ib Study of Lapatinib in Combination with Caelyx in Patients with Advanced HER2
positive pretreated Breast Cancer.
Treatment Plan:
Lapatinib is given at escalating doses orally and continuously on days 1-21. Caelyx is
administered at escalating doses in a 60-minute i.v. infusion on day 1. Each cycle is defined
as 21 days. Four dose levels are planned. Dose level -1, Caelyx 30 mg/mq & Lapatinib 1000 mg
die; dose level 1, Caelyx 30 mg/mq & Lapatinib 1250 mg die; dose level 2, Caelyx 30 mg/mq &
Lapatinib 1500 mg die; dose level 3, Caelyx 40 mg/mq & Lapatinib 1500 mg die. Three patients
will be initially enrolled in each dose level starting from level 1. If none of the first
triplet of patients will develop DLT, the dose will be escalated to the next level for the
subsequent three patients. If one of the first triplets of patients will develop first-course
DLT, a maximum of 3 additional patients will be entered at the same dose level. The MTD is
defined as the dose below that at which two patients have experienced DLT. Lapatinib will be
self-administered by the patient in an outpatient setting at the dose of the assigned step.
Patients will take the drug daily by mouth on days 1 to 21 of each cycle. Caelyx will be
administered by intravenous infusion over an exact period of 1 hour (preferably by a pump to
guarantee a constant speed of infusion) on day
1 of each cycle repeated every 21 days.
STATISTICAL METHODOLOGY:
Evaluation of toxicity: all patients will be evaluable for toxicity from the time of their
first treatment with Caelyx and Lapatinib.
Evaluation of response: all patients included in the study must be assessed for response to
treatment, even if there are major protocol treatment deviations or if they are ineligible.
All conclusions should be based on all eligible patients. Subanalyses may then be performed
on the basis of a subset of patients, excluding those for whom major protocol deviations have
been identified .However, these subanalyses may not serve as the basis for drawing
conclusions concerning treatment efficacy, and the reasons for excluding patients from the
analysis should be clearly reported. The 95% confidence intervals should also be provided.
Phase:
Phase 1
Details
Lead Sponsor:
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori